J. Pharm. BioTech Ind., Volume 3, Issue 3 (September 2026) – 4 articles

The therapeutic monoclonal antibody bevacizumab is typically purified using protein A affinity chromatography, a highly effective but costly method. Affinity-based precipitation for antibody purification is a lower-cost approach. In this work, a precipitation protocol was developed for bevacizumab purification using a branched peptide (Ac-PHQGQHIG-Ahx₃)₂-K-Ahx₃-PHQGQHIG-NH₂, which contains the epitope PHQGQHIG that is responsible for interacting with bevacizumab. The peptide was synthesised by a microwave-assisted solid-phase peptide method, employing LiCl as an additive to prevent aggregation and ensure high purity and yield. Three molecules of 6-aminohexanoic acid were introduced between each epitope branch as spacer arms to promote the formation of cyclic complexes. Bevacizumab purification from cell-free culture broth was achieved through a fractional precipitation process. First, a negative precipitation step using (NH₄)₂SO₄ 1.18 M was performed to remove contaminants. Afterwards, 5 moles of peptide per mol of bevacizumab was added to the supernatant, together with additional (NH₄)₂SO₄, to reach a final concentration of 1.20 M. Under these conditions, bevacizumab was recovered in the precipitate with 98% purity and a yield of 73%. In addition to being recyclable, the peptide’s relatively low production cost could enable the development of a single-use purification process, which would be particularly advantageous for biopharmaceutical manufacturing. Full article

Transdermal drug delivery offers several advantages over conventional routes. However, its use is limited by the low permeability of the stratum corneum. This limitation is especially significant in the case of hydrophilic drugs such as caffeine. This study explored microemulsion systems to enhance the transdermal delivery of caffeine (CF) using chemical penetration enhancers as cosurfactants. Kolliphor^® PS80 (PS80), Kolliphor^® RH40 (RH40), Kolliphor^® PS20 (PS20), and Kollicream^® OD (OD) were evaluated as cosurfactants for the first time in microemulsion formulations consisting of water, oil, and a fixed surfactant-to-cosurfactant ratio of 4:1 (w/w), with 14% of each cosurfactant incorporated. CF skin permeation from microemulsions was assessed via in vitro permeation studies using Franz diffusion cells and human cadaver skin. The results showed that OD-based microemulsions achieved approximately 3-fold higher CF skin permeation compared with the control formulation and 1.4–1.6-fold higher permeation compared with formulations containing PS80, RH40, and PS20. Furthermore, CF solubility in the four cosurfactants followed the order: PS20 > RH40 > PS80 > OD. These findings indicate that PS20 provides the highest solubility for CF among the tested cosurfactants. The results also included visual evaluations. No significant changes in appearance or physical properties were observed during the 10-month study. All samples remained clear and stable throughout the testing period. This study uniquely highlights the critical role of cosurfactant selection in optimizing microemulsion-based transdermal delivery systems. This work addresses a previously unexplored aspect, namely, the effect of cosurfactants with different physicochemical properties on the skin permeation of caffeine. The findings provide valuable insight into developing more effective transdermal and topical drug delivery systems. Full article

The development of strategies and processes to valorize cheese whey is an area of constant advancement and growth, primarily due to the large volume generated daily and inherent technical difficulties in cost-effectively processing this material. In this regard, the present perspective will discuss and analyze different strategies based on chromatographic innovations to develop processes that enable the direct and selective capture and purification of bovine lactoferrin (LF) and lactoperoxidase (LP) proteins from cheese whey. These proteins possess interesting commercial value and represent minor components of the whey protein fraction, with whey being their main source. Given that this issue is dedicated to the memory and career of Prof. Dr. Osvaldo Cascone, and considering his extensive research in this area, his contributions will be examined chronologically to illustrate the strategic technological advancements made by his research group. Specifically, the advancements achieved in terms of efficiency in the selectivity and purity obtained for the target proteins through the development of affinity chromatographic matrices and processes will be discussed, as well as the progress made in terms of whey processability. Full article

Background: Pharmaceutical innovation plays a vital role in advancing global health. This study evaluates the landscape of pharmaceutical innovation in the European Union (EU) over the 2011–2020 decade. Methods: A retrospective analysis was performed on new medicinal products containing new active substances (NAS) authorized between 2011 and 2020 through the centralized procedure. Products were categorized into first-in-class, advance-in-class, and addition-to-class. Trends in therapeutic areas (ATC codes), orphan designation, technology platforms, administration routes, and dosage forms were analyzed. Results: Across the decade, 357 new medicinal products received authorization. Of these, 56% were designated as first-in-class and 28% as advance-in-class, indicating that 84% of new products contributed substantive therapeutic innovation. Small molecules remained the predominant technology (63.5%), yet the decade also witnessed a pronounced expansion in monoclonal antibodies and the introduction of cell and gene therapies (Advanced Therapy Medicinal Products, ATMPs). The increased use of subcutaneous delivery systems, particularly for monoclonal antibodies, suggests a broader shift toward patient-centered administration routes. Conclusions: Between 2011 and 2020, pharmaceutical innovation in the European Union (EU) was characterized by a high rate of breakthrough innovations and a transition to more sophisticated biologic therapies. The EU could boost innovation further by refining expedited approval pathways (e.g., PRIME). Full article